Mentalizing and Epistemic Trust in Patients With Anxiety and Depression.

NCT06833567 | Recruiting

• 1 other identifier: MENT/CE_24
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial aims to evaluate the effects of mentalization-based group psychotherapy in patients diagnosed with anxiety and/or depression disorders. In total 100 users of mental health communitary services will be recruited for this study. Participants will be randomized in two parallel groups: to receive usual acceptance and commitment therapy group intervention (control group) or to receive brief mentalization-based group psychotherapy (intervention group). Participants in the trial will be assessed at baseline and at 3 months.

Conditions

Anxiety Disorders; Depression

Outcome Measures

Primary Outcomes (2)

• Change from baseline anxiety symptoms at 3 months.

  Generalized Anxiety Disorder 7-item scale (GAD-7), is a self-report questionnaire used to assess the severity of generalized anxiety disorder symptoms. It consists of seven questions that ask respondents to rate how often they have experienced various anxiety-related symptoms over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day), allowing for a total score ranging from 0 to 21. Higher scores indicate greater anxiety severity. The Spanish adaptation used in this study has excellent psychometric properties, with a Cronbach's alpha of .94

  At baseline then at 3 months.

• Change from baseline depressive symptoms at 3 months.

  Patient Health Questionnaire-9 (PHQ-9) is a self-report tool designed to assess the severity of depression symptoms. It consists of 9 questions using a Lykert-type scale from 0 (not at all) to 3 (nearly every day). Respondents are asked to rate how often they have experienced specific symptoms over the past two weeks. The total score can range from 0 to 27, with higher scores indicating more severe depressive symptoms.

  At baseline then at 3 months.

Secondary Outcomes (5)

• Change from baseline epistemic trust at 3 months.

  At baseline then at 3 months.

• Change from baseline epistemic trust, Mistrust and Credulity at 3 months

  At baseline then at 3 months.

• Change from baseline reflective functioning at 3 months.

  At baseline then at 3 months.

• Change from baseline functional impact at 3 months.

  At baseline then at 3 months.

• Satisfaction with therapy

  At 3 months

Study Arms (2)

Brief mentalization-based group psychotherapy

EXPERIMENTAL

Participants will attend mentalization-based psychotherapy group sessions of 12 weekly sessions.

Behavioral: Brief mentalization-based group psychotherapy

Acceptance and commitment therapy group intervention

ACTIVE COMPARATOR

Participants will attend to usual group intervention based on Acceptance and Commitment Therapy of 12 weekly sessions.

Behavioral: Acceptance and Commitment Therapy group intervention

Interventions

Brief mentalization-based group psychotherapy BEHAVIORAL

The intervention is an adaptation for anxiety and depression profiles of the introductory group program to Mentalization-Based Treatment for personality disorders. Sessions program: * Session 1: Building epistemic trust. * Session 2: Introduction to mentalization. * Session 3: Mentalization problems. * Session 4: Emotions. * Session 5: Mentalizing emotions. * Session 6: Attachment relationships. * Session 7: Attachment and mentalization. * Session 8: Interpersonal relationships. Mentalizing relationships in the group. * Session 9: Anxiety, attachment and mentalization. * Session 10: Depression, attachment and mentalization. * Session 11: Flexible content depending on pending topics or participants' needs. Preparing for closing * Session 12: Final balance and closing.

Brief mentalization-based group psychotherapy

Acceptance and Commitment Therapy group intervention BEHAVIORAL

The intervention includes 12 sessions based on Acceptance and Commitment Therapy. Sessions program: * Session 1: Presentation. * Session 2: Cognitive defusion * Session 3: Uncontrollability of thought, emotions and behavior. * Session 4: Creative Hopelessness. * Session 5: Mindfulness and acceptance. * Session 6: Values. * Session 7: Values and action. * Session 8: Vital goals. * Session 9: Goal achievement plan. * Session 10: Implementation. * Session 11: Flexible content depending on pending topics or participants' needs. Preparing for closing * Session 12: Final balance and closing.

Acceptance and commitment therapy group intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are 18 years or older.
• Participants have a diagnosis of ICD-10 F32, F33, F34, F41.1, F41.2, F43 or F43.2.
• Participants have minimal relational skills to participate in group therapy.
• Participants agree to be part of the study by giving signed written consent.

You may not qualify if:

• Participants have a diagnosis of ICD-10 F10-19, F20-29, F31, F42, F43.1, F60.
• Participants with cognitive deficits assessed during the initial interview or diagnosis of ICD-10 F70-79.
• Participants with planning or structured suicidal ideation.
• Participants with difficulties in relational skills evaluated during the initial interview.

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: lead

Study Sites (1)

Instituto de Investigacion Biomedica de Malaga - IBIMA

Málaga, Malaga, 29009, Spain

RECRUITING

Related Publications (8)

• Luyten P, Campbell C, Allison E, Fonagy P. The Mentalizing Approach to Psychopathology: State of the Art and Future Directions. Annu Rev Clin Psychol. 2020 May 7;16:297-325. doi: 10.1146/annurev-clinpsy-071919-015355. Epub 2020 Feb 5.

  PMID: 32023093 BACKGROUND

• Fonagy P, Luyten P, Allison E, Campbell C. Mentalizing, Epistemic Trust and the Phenomenology of Psychotherapy. Psychopathology. 2019;52(2):94-103. doi: 10.1159/000501526. Epub 2019 Jul 30.

  PMID: 31362289 BACKGROUND

• Campbell C, Tanzer M, Saunders R, Booker T, Allison E, Li E, O'Dowda C, Luyten P, Fonagy P. Development and validation of a self-report measure of epistemic trust. PLoS One. 2021 Apr 16;16(4):e0250264. doi: 10.1371/journal.pone.0250264. eCollection 2021.

  PMID: 33861805 BACKGROUND

• Ruiz-Parra E, Manzano-Garcia G, Mediavilla R, Rodriguez-Vega B, Lahera G, Moreno-Perez AI, Torres-Cantero AM, Rodado-Martinez J, Bilbao A, Gonzalez-Torres MA. The Spanish version of the reflective functioning questionnaire: Validity data in the general population and individuals with personality disorders. PLoS One. 2023 Apr 6;18(4):e0274378. doi: 10.1371/journal.pone.0274378. eCollection 2023.

  PMID: 37023214 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.

  PMID: 11983645 BACKGROUND

• Knapen S, Swildens WE, Mensink W, Hoogendoorn A, Hutsebaut J, Beekman ATF. The development and psychometric evaluation of the Questionnaire Epistemic Trust (QET): A self-report assessment of epistemic trust. Clin Psychol Psychother. 2023 Nov 10. doi: 10.1002/cpp.2930. Online ahead of print.

  PMID: 37947067 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Maria Traverso Rodriguez

CONTACT

+34 660512210; mariatraverso8@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 18, 2025
• Study Start: April 28, 2024
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

ES (1)